Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25, 50, and 100%
No. of animals per dose:
5
Details on study design:
The study was performed according to OECD testing guideline 429.
Statistics:
For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test or the Student Newman Keuls test. Statistical significance was set at the five per cent level (p < 0.05). The Dean-Dixon-Test was used for identification of possible outliers (performed with Microsoft Excel 2003).

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: vehicle control: 1.00 25%: 1.37 50%: 1.44 100%: 4.74
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: vehicle control: 650.7 (mean) 25%: 889.1 (mean) 50%: 940.1 (mean) 100%: 3084.1 (mean)

Any other information on results incl. tables

calculation of the EC3:

Test item concentration %

S.I.

 

50 (c)

1.44 (d)

 

100 (a)

4.74 (b)

 

EC3 = (a-c) [(3-d)/(b-d)] + c =73.6%(w/w)

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test item 3, 4-Dihydro-2H-pyrane was found to be a skin sensitiser in the Local Lymph Node Assay.
Executive summary:

3,4-Dihydro-2H-pyrane was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) in mice. The test was performed using test item concentrations of 25 and 50% (w/w) in acetone:olive oil (4+1 v/v) and 100% (undiluted test item).

In this study Stimulation Indices (S.I.) of 1.37, 1.44, and 4.74 were determined with the test item at concentrations of 25 and 50%, and 100%, respectively. A dose response was observed. An outlier was not identified in any of the tested groups. The EC3 value calculated was 73.6%. A statistically significant and biologically relevant increase in DPM value, lymph node weight and - cell count was observed in the high dose group (100%) in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was exceeded in the high dose group.